Analysis of the work of qualification of suppliers of pharmaceutical ingredients Unit Farmanguinhos

Considerando a estreita rela????o entre a l??gica econ??mica e as necessidades da ??rea de sa??de, o estudo em quest??o interliga o trabalho de Qualifica????o de Fornecedores de Insumos Farmac??uticos com o desempenho produtivo das Ind??strias Farmac??uticas no contexto do Complexo Industrial da Sa??de. Como objetivo evidencia o inter-relacionamento de ordem administrativa, t??cnica e operacional, frente o desempenho articulado entre os Procedimentos internos adotados por Farmanguinhos, seus processos de Aquisi????o, Valida????o, Manufatura e Inova????o de Medicamentos, e a Qualidade e Especificidade dos Insumos Farmac??uticos adquiridos, demonstrando dentro desta ambi??ncia, o impacto promovido pelo Trabalho de Qualifica????o de Fornecedores, em conformidade com os requisitos de qualidade visando ??s Boas Pr??ticas de Fabrica????o. Como referencial te??rico e regulat??rio, fundamenta al??m do contexto econ??mico, pol??tico e institucional capitalista associado ?? produ????o de bens e servi??os do Complexo Industrial da Sa??de, a representatividade da Ind??stria Farmac??utica frente ?? balan??a comercial nacional e desenvolvimento econ??mico, a conex??o de conformidades entre os trabalhos de Valida????o e as Boas Pr??ticas de Fabrica????o, bem como a interdepend??ncia entre a especificidade dos insumos farmac??uticos, seus processos de aquisi????o pelo setor p??blico e os trabalhos de qualifica????o de fornecedores, tudo no ??mbito da cadeia de produ????o de medicamentos. O impacto destes fundamentos frente ?? din??mica administrativa, t??cnica e operacional produtiva de Farmanguinhos ?? evidenciado por informa????es oriundas de pesquisa explorat??ria, documental e de campo, empregada na metodologia de interven????o. Na an??lise de campo foram evidenciados procedimentos adotados por Farmanguinhos, relacionados com a aquisi????o pela administra????o p??blica e com a qualifica????o de fornecedores de insumos farmac??uticos, apresentando diagn??stico dos ??ndices de reprova????es das mat??rias-primas e medicamentos manufaturados e sua repercuss??o frente ?? demanda programada pelo Minist??rio da Sa??de. Integrada ?? meta de excel??ncia operacional de Farmanguinhos, a proposta identifica na Qualifica????o de Fornecedores, apoiada pelos trabalhos de Valida????o e Aquisi????es, estabilidade nos processos de inova????o e manufatura, fortalecendo estrat??gias industriais e atendimento as demandas do Sistema ??nico de Sa??de.Considering the relation between the economic logic and the necessities of the health area, the study in subject establishes connection the Raw Pharmaceutical Suppliers Qualification???s Work with the productive performance of the Pharmaceutical Industries in the context of the Health Industrial Complex. As objective it evidences the Inter-relationship of administrative, operational and technique orders, front of the articulated performance of the internal Procedures adopted by Farmanguinhos, its processes of Acquisition, Validation, Manufacture and Innovation of Medicines, and the Quality Specified Raw Pharmaceutical acquired, demonstrating inside of this environment, the impact promoted for the Suppliers Qualification???s Work, in compliance with the Good Manufacturing Practices quality requirements. As regulatory and theoretician referential, it bases beyond the economic, politician and institutional capitalist context associated with the production of goods and services of the Health Industrial Complex, the representation of the Pharmaceutical Industry front to the national trade balance and economic development, the connection of conformity between the Validation???s work and the Good Manufacturing Practices, as well as the interdependence enters the specificity of the Raw Pharmaceutical, its public acquisition processes and the supplier qualification works, everything in the scope of the chain of medicine production. The impact of these bases front to the Farmanguinhos administrative, productive and operational technique dynamics is evidenced by deriving information of exploratory research, documentary and of field, used in the intervention methodology. In the field analysis procedures adopted for Farmanguinhos had been evidenced, related with the acquisition for the public administration and with the Raw Pharmaceutical Suppliers Qualification???s Work presenting diagnostics of the raw materials and manufactured medicines disapprove index and its repercussion front to the demand programmed for the Health Ministry. Integrated to the goal of Farmanguinhos operational excellency, the proposal identifies in the Suppliers Qualification, supported for the works of Validation and Acquisitions, stability in the innovation processes and manufactures, fortifying industrial strategies and attendance the demands of the Health System